GENTAMICINA 0.1 % Cream

Зміст інструкції

1. Gentamicina Hexal 0.1% cream
   1. What is Gentamicina Hexal and what is it used for
   2. What you need to know before using Gentamicina Hexal
   3. How to use Gentamicina Hexal
   4. Possible side effects
   5. How to store Gentamicina Hexal
   6. Contents of the pack and other information

Gentamicina Hexal 0.1% cream

Gentamicina solfato

Equivalent medicine

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Gentamicina Hexal is and what it is used for
• 2. What you need to know before using Gentamicina Hexal
• 3. How to use Gentamicina Hexal
• 4. Possible side effects
• 5. How to store Gentamicina Hexal
• 6. Contents of the pack and other information

1. What is Gentamicina Hexal and what is it used for

Gentamicina Hexal is a cream for topical application that contains the active ingredient gentamicin which
belongs to the group of medicines called aminoglycoside antibiotics, used against bacterial infections.
Gentamicina Hexal is indicated for the treatment of skin inflammations caused by bacteria such as:

• skin infections with lesions characterized by blisters, vesicles and pustules which, when broken, lead to a lesion that heals with difficulty (ecthyma), boils (furunculosis), eczemas caused by microorganisms (microbial eczema), stasis ulcers and traumatic lesions;
• inflammation of the skin where hair grows (folliculitis), inflammation of hairy areas (sycosis);
• secondary bacterial infections of skin lesions (impetigo);
• infected burns and abrasions;
• inflammatory conditions with pimples (acne);
• a chronic inflammatory skin disease involving the immune system (pustular psoriasis);
• inflammations of the skin caused by continuous friction of two parts of the body (intertrigo);
• disease of the superficial layers of the skin and nails (perionychia) of bacterial origin.

Gentamicina Hexal is particularly indicated in forms that have appeared recently (acute) accompanied by the
presence of inflammatory fluid (in the exudative phase).
In skin diseases caused by fungi, Gentamicina Hexal is not effective, as gentamicin is not
active against any type of fungus.
The medicine can be used in bacterial infections that develop where fungal or viral infections already exist.

2. What you need to know before using Gentamicina Hexal

Do not use Gentamicina Hexal

• if you are allergic to the active ingredient, to similar substances or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Consult your doctor or pharmacist before using Gentamicina Hexal.
Do not use this medicine in the eyes.
Stop treatment and inform your doctor if you experience irritation or an allergic reaction
(sensitization) following the use of this medicine, especially for prolonged periods.
Prolonged and excessive use of gentamicin, as well as other antibiotics, may lead to the development of resistant microorganisms; in this case, your doctor will advise you to discontinue treatment and
prescribe suitable therapy.
Use the medicine with caution and inform your doctor if you are allergic to other antibiotics of the
aminoglycoside group, as an allergic reaction (cross-hypersensitivity) may occur.
Avoid the concurrent and/or sequential use of other medicines that cause kidney toxicity (nephrotoxic) and/or brain toxicity (neurotoxic) systemically or topically.
The systemic absorption (into the bloodstream) of topical gentamicin increases when treating extensive areas of the
body, especially in the presence of skin damage or in case of long-term treatments. In this case,
undesirable effects that manifest with systemic use of gentamicin may occur. Keep this in mind
especially when treating infants or children.
Gentamicina Hexal is not active in skin infections caused by viruses and fungi.

Children
In early infancy, this medicine should only be used if absolutely necessary and under the
direct supervision of a doctor.

Other medicines and Gentamicina Hexal
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
No interactions with other medicines are known at this time.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with breast milk
ask your doctor or pharmacist for advice before using this medicine.
If you are pregnant, use this medicine only if absolutely necessary and under the direct
supervision of a doctor. Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

Gentamicina Hexal contains chlorocresol andcetostearyl alcohol
This medicine contains chlorocresol, which may cause allergic reactions.
This medicine contains cetostearyl alcohol, which may cause skin contact reactions (e.g. contact dermatitis).

3. How to use Gentamicina Hexal

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any doubts
consult your doctor or pharmacist.
Gentamicina Hexal should not be applied to the eyes.
Apply a small amount of cream to the affected area 3-4 times a day until results are achieved.
After that, you can reduce applications to 1-2 times a day.
Protect the treated area with a sterile gauze after applying the cream.

If you use more Gentamicina Hexal than you should
In case of ingestion/accidental intake of Gentamicina Hexal, immediately inform your doctor or
go to the Emergency Room of the nearest hospital.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

If you forget to use Gentalyn
Do not use a double dose to make up for a missed dose.

If you stop treatment with Gentalyn
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur:

• allergic contact reactions;
• temporary skin irritation such as erythema or itching which usually does not require discontinuation of therapy. Reporting of side effectsIf you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Gentamicina Hexal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label after “Scad”.
The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in waste water or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Gentamicina Hexal contains

• The active ingredient is gentamicin. 100 g of cream contains 0.166 g of gentamicin sulfate, equivalent to 0.1 g of gentamicin.
• The other ingredients are: liquid paraffin, white petrolatum, chlorocresol, cetomacrogol, cetostearyl alcohol, sodium phosphate monobasic, purified water.

Description of the appearance of Gentamicina Hexal and contents of the pack
Pack containing a tube of 30 g of cream.

Marketing Authorisation Holder
Sandoz S.p.A., Largo U. Boccioni 1, 21040, Origgio (VA) Italy

Manufacturers
Doppel Farmaceutici Srl - Via Martiri delle Foibe 1 – 29016 Cortemaggiore (PC)
Mipharm S.p.A. – Via B. Quaranta, 12 – 20141 Milano